0 T Many, many of my patients love their pump. /Subtype /Link The company Tactile medicine has been so nice from listening to me to appealing and sending people to me to make the process easy. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of the Companys control that can make such statements untrue, including, but not limited to, the impacts of the COVID-19 pandemic on the Companys business, financial condition and results of operations; the course of the COVID-19 pandemic and its impact on general economic, business and market conditions; the Companys inability to execute on its plans to respond to the COVID-19 pandemic; the adequacy of the Companys liquidity to pursue its business objectives; the Companys ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives, including prior to identifying a successor; adverse economic conditions or intense competition; loss of a key supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of the Companys products; technical problems with the Companys research and products; the Companys ability to expand its business through strategic acquisitions; the Companys ability to integrate acquisitions and related businesses; price increases for supplies and components; the effects of current and future U.S. and foreign trade policy and tariff actions; or the inability to carry out research, development and commercialization plans. /TT1 23 0 R * American Society of Clinical Oncology 1. /Type /Group /CropBox [0.0 0.0 612.0 792.0] stream Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum. /Filter /FlateDecode Non-cancer related lymphedema patients demonstrated a: 75% decline in the rate of cellulitis, a 40% reduction in the rate of out-patient hospital visits, a 34% reduction in rate of physical therapy visits, and a 36% reduction in lymphedema-related costs. I use it everyday for an hour. In the first randomized control trial of home management of head and neck lymphedema, Vanderbilt researchers found statistically significant improvements with Flexitouch users1. Positive value shows an increase in Function/Range of Motion. HQK0)I46IC">bY3oons} K.4V./`\f0 Fs I go to wound care once a week because of the horrible wounds on my legs that drain so badly due to the lymphedema. /Kids [3 0 R 4 0 R 5 0 R 6 0 R 7 0 R 8 0 R 9 0 R] /Tabs /S Also, when I am out of my sleeve for special occasions, the knuckles of my hand are still showing after a few hours. Another set of pads enveloped my left thigh and trunk. I met other therapists here and there and all of them preferred manual lymphatic drainage, MLD, over the use of pumps. /Im0 60 0 R NMG/ )!s0nhM'k3Kb3.#r7{tb|A:W5`~k786n]=nm]K1=^O yKb( << /A << Listing a study does not mean it has been evaluated by the U.S. Federal Government. It has become so bad that I can barely walk. /A << endstream by Flexitouch. I wonder if pumps can be reprogrammed. Ridner, S.H., et al., A prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Last updated March 2021. Ridner, S.H., et al., A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. My husband has a brand new system that Im trying to sell. Since using the Flexitouch for almost a year, she had not experienced cellulitis. >> The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. I decided to purchase one without insurance. It takes just 32 minutes per day. >> Negative value shows a decrease in symptoms/problems. Phone: 1.612.355.5100 Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) 2. Ridner, S.H., Dietrich, M.S., Deng, J. et al. You have to speak up for yourself because my doctor would have just let me keep getting it and pumping me full of antibiotics. The pump has helped you achieve significant results. /StructParents 0 /TT0 69 0 R +t}}lZA5'a^M~+y'A]rY(gA\`a||""1DE h2vIvMzLY$"'q!Wb40Jbc=&EMFEkl4F6,{~BP {%AIqEWRA>, I have been having weekly physical therapy to help with lymphedema and range of motion issues. /Tabs /S I have been suffering from lymphedema for the past 2 years. Most significantly was the reduction in my forearm. >> Looking at his ankles there IS no swelling now. /CropBox [0.0 0.0 612.0 792.0] document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); This site uses Akismet to reduce spam. They are in contact with patients who could benefit from a pneumatic pump. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. >> 13 0 obj Its brand new, used 1 time. endobj What do I think about my Flexitouch, or spacesuit as my husband and I affectionately call it Im glad I have it. The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. For the year ended December 31, 2022, we generated revenue of $246.8 million and had a net loss of $17.9 million, compared to revenue of $208.1 million and a net loss of $11.8 million for the year . << /Rect [90.257 252.64 421.33 266.44] >> The Flexitouch Plus helps to improve the lives of patients who have struggled with the pain, swallowing, speaking and breathing difficulties brought on by head and neck lymphedema. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. EJVES. stream Find many great new & used options and get the best deals for Ping G15 Irons / 4-PW / Green Dot / Regular Flex Ping TFC 149 I Shafts at the best online prices at eBay! An estimated 1.4 million U.S. patients are diagnosed with lymphedema annually. endstream stream It was a blow to the life I had that I once had. O ce they are used the government wont always them to use them on another. /Type /Action I was rather startled at how wrapped up I was. /StructParents 0 During cancer treatment, tumors, surgery and radiation can cause damage to the lymphatics. /ExtGState << endobj 18 0 obj Information provided by (Responsible Party): The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer. They are programed for each individual. Co-Primary Investigators for the study are Ridner and Barbara Murphy, MD, professor of Medicine, Vanderbilt University School of Medicine. /CS /DeviceRGB Numerous clinical studies show achievement of major clinical benefits and cost savings Percentage of each response captured. Securities registered pursuant to Section 12(g) of the Act: None (Title of class) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 This combination of products and services ensures that tens of thousands of patients annually receive the at-home treatment necessary to better manage their chronic conditions. In the last year and a half I was getting cellulitis in my right leg about every 3-4 months and the last straw was in both. Toll-free: 1.833.3TACTILE (1.833.382.2845) /C2_0 21 0 R /StructParent 1 /Contents 73 0 R Subject overall health and quality of life in the past week-EORTC C30. 12 0 obj /Type /Page /BS << /Font << Forward-looking statements are generally identifiable by the use of words like may, will, should, could, expect, anticipate, estimate, believe, intend, continue, confident, outlook, guidance, project, goals, look forward, poised, designed, plan, return, focused, prospects or remain or the negative of these words or other variations on these words or comparable terminology. /Filter /FlateDecode The Flexitouch system is clinically proven to improve clinical outcomes and reduce healthcare costs, stimulate lymphatic function, and significantly reduce edema and limb volume. Pneumatic Compression Device Treatment of Lower Extremity Lymphedema Elicits Improved Limb Volume and Patient-Reported Outcomes. Sort by. I was told purchased high priced left garments which I dont think I needed. >> They are usually called something like 7 on your side or Channel 3 helps you. Head and neck cancer treatments often lead to lymphedema a chronic swelling condition that may be caused by damage to the lymphatic system. Im only 44 years old , and I have kids that need mom back. Sacco, A. G., Chen, R., Worden, F. P., Wong, D. J. L., Adkins, D., Swiecicki, P., Cohen, E. E. W. (2021). Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. /Parent 2 0 R All reviewers. >> Numerous garment and program options to meet each patient's unique treatment needs /Pages 2 0 R How customer reviews and ratings work See All Buying Options. I am looking for a left arm garment for the flexitouch plus. Minneapolis, MN 55416 USA /Annots [25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R They will reach out to Flexitouch in the process of creating a segment for the news. The trial will compare the short- and long-term effectiveness of Tactile Medicals Flexitouch Plus system to usual care, such as complete decongestive therapy (CDT), for the management of lymphedema and fibrosis in head and neck cancer survivors. View this study on Beta.ClinicalTrials.gov, Study Protocol and Statistical Analysis Plan, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Then one evening last fall when I was arriving at a SWELL lymphedema support meeting I heard a buzz in the air. The initiation of this clinical trial underscores Tactile Medicals commitment to supporting the development of quality clinical evidence and expanding access to effective lymphedema treatment for this underserved patient population., For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events. I have lymphedema near globally at this point and am trying to obtain coverage via insurance. It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. /Resources << With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema, said Sheila Ridner, PhD, RN, FAAN, Professor of Nursing, Emerita, Vanderbilt University School of Nursing, a principal investigator of the trial. She advocated instead for daily manual lymphatic drainage and the wearing of compression garments. Direct Evidence of Lymphatic Function Improvement After Advanced Pneumatic Compression Device Treatment of Lymphedema. << /Tabs /S /MediaBox [0 0 612 792] /Rotate 0 Except for my wrist, all my measurements showed reduction. One week at the wound care clinic , I saw a different doctor than normal and he referred me to tactile. Phone: 1.612.355.5100 46(4): 480487. >> /StructParents 0 If you still have the system, I am interested. I have skipped 1 or 2 days just 3 or 4 times since March. endobj Apply garment(s), plug garment hose into pump controller, turn controller on and push button to begin treatment. /TT2 72 0 R The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. Im curious, was your husband diagnosed with lymphedema or was his leg swelling due primarily to diabetes? Percent change is calculated by the difference between swelling measurements averaged at 6 months versus baseline. Entre for Upper Body; Entre System User Guide and Additional Information for Upper Body; Flexitouch Plus for Upper Body; Flexitouch Plus User Guide and Additional Information for Upper Body; Lower Body. I did a baseline measurement of my left arm before treatment and three weeks after using the pump. D/N500187-000-00 Rev. /TT0 56 0 R I tried to buy the garments I need from the company and they wont sell me the sleeves I need because I bought the machine from a 3rd party. Yes, taking care of ones body requires several interventions. I know many others can as well. >> No, I still cant play for hours upon hours but I can play an hour straight, take a break, and play some more. }3eIH]^p~>_ y#h`*#OPQB_lVI"p! /Resources << The Cutaneous, Net Clinical, and Health Economic Benefits of Advanced Pneumatic Compression Devices in Patients With Lymphedema. I cant afford to buy new so I opted to get one used to at least start my therapy the PT has ordered. /Count 7 I went through a period of reducing with bandaging and compression bras and sleves and swell spots, tribute night garmets, flatknit sleeves and gauntlets, hours of MLD myself (still using the arm that I need to not be using) paying out of pocket thousands of dollars for professional lymph massage that insurance wouldnt pay for. >> /Tabs /S If Im out late, I use it in the morning and then resume again in the evening. My husband?s pump system arrived yesterday. Selling one at a reduced cost could open up possibilities for people who could not otherwise afford them. Talk with your doctor and family members or friends about deciding to join a study. stream For these patients, Flexitouch Plus for head and neck lymphedema is the first and only pneumatic compression device cleared and commercially available to treat this condition at home. I keep them on the floor (in a quiet out of the way spot ) protected by a large bedsheet that is folded in half - all the pieces are laid on top of one another with the top half of the sheet over the top of the garments (like a sandwich) . /Font << The company approached Nottingham Spirk to develop a first-to-market pneumatic compression garment for use on the head and neck and to create the next generation Flexitouch Plus System. The Flexitouch system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema. Hi Karyn, I will post your comment and see if Sarah still has the pump available. Ridner, S.H., Dietrich, M.S., Deng, J. et al. We were asked to improve the ease of donning . Radiation: Radiation can cause scarring and damage to the lymph nodes and vessels, affecting their ability to remove lymph fluid from the area. I just finished 6 weeks of radiation. << /TT0 22 0 R Ive had my Flexitouch for almost five months. Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. 3701 Wayzata Blvd, Suite 300 The leg garments that I received are for a much taller person. /CropBox [0 0 612 792] Tactile Systems Technology, Inc. /URI (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) Ive heard from many people that they saw good results with their pump. In addition, other factors that could cause actual results to differ materially are discussed in the Companys filings with the SEC. >> >> My insurance paid for all of it and the Tactile rep will help you get that. I have lymphedema in my right arm, breast and axilla. The Companys unique offering includes advanced, clinically proven pneumatic compression devices, as well as continuity of care services provided by a national network of product specialists and trainers, reimbursement experts, patient advocates and clinicians. Its something Im passionate about. /TT0 69 0 R About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features Press Copyright Contact us Creators . S The Flexitouch Plus system applies mild, dynamic pressure to stimulate lymphatic function and direct fluid away from impaired areas toward healthy, functioning regions where the fluid can be managed. I use it every evening. The study documented a reduction in the rate of cellulitis episodes following use of the Flexitouch System for the treatment of lymphedema. << Subjects diagnosed with Head and Neck Lymphedema and prescribed the Flexitouch system or Flexitouch Plus system as standard of care treatment, Device: Flexitouch system with Head and Neck Garments. I have searched the usual places, such as ebay, but cannot find a left arm garment anywhere. The sores he used to get on his legs are healing faster; he says he doesnt feel anywhere near as sluggish. /Parent 2 0 R Percent change is calculated by the difference between scores averaged at 6 months versus baseline. /S /Transparency /Rotate 0 To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Read our, ClinicalTrials.gov Identifier: NCT03558672, Observational FLEXITOUCH Compression Unit For Left Shoulder Short sz 3 Trunk PD32-U Pump Lymphedema Pump Lymphedema For Sale Compression Unit For Left Shoulder Short. /TT2 74 0 R 5. I have been thru way to much of trial and error doctors and a lymphedema physical therapist which was a joke. /Type /Group Please cross your fingers for me that this works. Detailed Description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. Many head and neck cancer survivors are faced with an additional challenge: lymphedema. This damage can cause the lymph fluid to pool instead of flow, leading to debilitating internal and external swelling. The head and neck application of the Flexitouch system received 510 (k) pre-market notification clearance from the FDA in August of 2016. /F 4 Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck: A Randomized Wait-List Controlled Trial. Tactile Medicals Mission is to help people suffering from chronic diseases live better and care for themselves at home. ?gF:cmlrpoc*teIgeF%hvK-h*NHw\3b.IkQvll Bwzw6Gix-Gm6!57Z4T$YNN I see several for sale on EBAY, but the lymphedema community is such a specific niche, I just dont think thats the best way to approach the need. And sure enough, even with the improvement I experienced from PT, I couldnt play more than 15 minutes without excessive swelling. Chronic pain all the time and the hopelessness of diagnosis was almost harder than going through chemo emotionally and physically. Flexitouch Plus is the only FDA cleared pneumatic compression device for head and neck cancer-related lymphedema and can be prescribed during routine follow up care. Lymphedema is a failure of lymphatic system to transfer fluid from the connective tissue to the circulatory system. . During pregnancy (applies only to the Flexitouch Plus trunk accessory). Buying a reconditioned machine saved me some money. The pump, created by Tactile Medical, provides compression to the skin which is a key to treating. /C2_0 38 0 R So we appealed 3 times. I like to joke, Honey, time for me to put the squeeze on you I can relate all too well to what you have been through. I dont like that I have to do it but it has changed my legs back to normal. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Percent change is calculated by the difference between scores averaged at 6 months versus baseline. MINNEAPOLIS, Sept. 30, 2021 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (Tactile Medical) (Nasdaq: TCMD), a medical technology company focused on developing medical devices for the treatment of chronic diseases at home, today announced the enrollment of the first patient in a randomized, controlled clinical trial evaluating the effectiveness of its Flexitouch Plus system for the treatment of head and neck lymphedema. https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. Learn More Take the steps now to help your head and neck cancer survivors. endobj Percent change is calculated by the difference between measurements averaged at 6 months versus baseline. Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. >> XJ Positive value shows an increase in swelling. Head and Neck Lymphedema Treatment Flexitouch Plus provides a comfortable, effective, at-home treatment designed to help head and neck lymphedema patients get back to their lives. More than 90% of patients treated for head and neck cancer develop lymphedema1 resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life with few viable options for long-term treatment, said Dr. Thomas F. ODonnell, Jr., Tactile Medicals Chief Medical Officer. I purchased a barely used unit but tactile will not sell me the garment since I havent purchased a new machine from them. << Hi Kathi, The FaceTime call might work! /A << It will consist of approximately 250 subjects enrolled at six clinical sites: Vanderbilt University Medical Center, University of Michigan, Johns Hopkins University, University of Kentucky, Rush University and University of Alabama. (Note: There are other well regarded pumps on the market. Thank you for sharing your husbands success with a pump. D 12/2020, Tactile Medical Announces Enrollment of First Patient in Randomized, Controlled Clinical Trial Evaluating the Effectiveness of Flexitouch Plus for the Treatment of Head and Neck Lymphedema, Flexitouch User Guide and Additional Information for Head and Neck, Entre System User Guide and Additional Information for Upper Body, Flexitouch Plus User Guide and Additional Information for Upper Body, Entre System User Guide and Additional Information for Lower Body, Flexitouch Plus User Guide and Additional Information for Lower Body, https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/, https://tactilemedical.com/information-for-patients/what-is-lymphedema/, https://tactilemedical.com/our-lymphedema-solutions/for-head-and-neck/flexitouch-plus/. In conducting this rigorous clinical trial, we hope to build on the initial body of evidence by evaluating the effectiveness of Flexitouch Plus in comparison to usual care, using a variety of measures to assess the benefits of this at-home treatment for patient health and quality of life.. trunk and full leg, The legs dont inflate until the last 15 minutes of the cycle, and then the pressure is very weak in all of it, I can barely fill it, Its not nothing like the one I experienced at the dr office.. K-ZB: >> Hi Wally, Hope someone is able to meet your request. Repeatable results and high patient satisfaction encourage ongoing use and better outcomes. To evaluate function based upon cervical and shoulder range of motions measurements from baseline to 6 months of treatment with the Flexitouch System or Flexitouch Plus. Anyway, we are excited and hopeful this will be a part of our answer for his lymphedema. /Parent 2 0 R Tactile Medical manufactures pneumatic compression devices that allow lymphedema patients to self-manage at home. Tens of thousands of. /Group << My best to you. /StructParents 8 Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. I developed secondary lymphedema about 2 years ago after I had 3 sentinel nodes taken out with a lumpectomy, chemo and 36 doses of radiation.
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